title: Volumizing hyaluronic acid filler for midface volume deficit: 2-year results from a pivotal single-blind randomized controlled study.
abstract: BACKGROUND
  Hyaluronic acid (HA) gels are commonly used to correct age-related midface volume deficit (MVD), yet the Food and Drug Administration has not specifically approved them for this purpose.
  
  
  OBJECTIVE
  To study the safety and effectiveness of a new 20-mg/mL HA gel (VYC-20L) specifically formulated and optimized for mid-face volumizing.
  
  
  METHODS
  A multicenter, single-blind, controlled study randomized 235 subjects aged 35 to 65 with MVD to a treatment group and 47 to a no-treatment control group. Responders were defined as subjects who achieved improvement of 1 point or more on the validated 6-point Mid-Face Volume Deficit Scale (MFVDS) at 6 months as rated live by two blinded independent evaluators. The primary endpoint required a 70% or greater treatment group response and a statistically significant difference (p < .001) between the treatment and control group responder rates.
  
  
  RESULTS
  The primary endpoint was met, with 85.6% of the treatment group improving by 1 point or more on the MFVDS at month 6 and a statistically significant difference (p < .001) between the treatment and control group responder rates. Subjects tolerated VYC-20L well, with no unanticipated adverse device effects. Nearly half of subjects maintained correction for 24 months.
  
  
  CONCLUSIONS
  VYC-20L is safe and effective for age-related MVD, with correction lasting up to 2 years.
authors.affiliation: Department of Dermatology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California; Skin Care Laser Physicians of Beverly Hills, Los Angeles, California.
authors.forename: Derek
authors.initials: D
authors.lastname: Jones
authors.forename: Diane K
authors.initials: DK
authors.lastname: Murphy
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D001672:Biocompatible Materials; D003357:Cosmetic Techniques; D003879:Dermatologic Agents / Q000627:therapeutic use*; D005145:Face; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D001672:Biocompatible Materials; D003879:Dermatologic Agents; D005782:Gels; D006820:Hyaluronic Acid